Solpaflex - instructions for use, dose, side effects, contraindications

Composition:Each tablet contains:
active substance - Ibuprofen 200 mg.
Excipients - corn starch, microcrystalline cellulose, lactose, magnesium stearate, silicon dioxide colloid, croscarmellose sodium, hypromellose, triacetin.

Description:White, oval, film-coated tablets, with even edges, engraved "H200" on one side and smooth on the other.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

M.01.A.E.01 Ibuprofen

Pharmacodynamics:Has anti-inflammatory, antipyretic and antiplatelet effect. Suppresses inflammatory factors, reduces platelet aggregation. By depressing cyclooxygenases of types 1 and 2, it breaks the metabolism of arachidonic acid, reduces the amount of prostaglandins both in healthy tissues and in the focus of inflammation, suppresses the exudative and proliferative phases of inflammation. Reduces pain sensitivity in the focus of inflammation. It causes a weakening or disappearance of the pain syndrome, incl. with pain in the joints at rest and during movement, a decrease in morning stiffness and swelling of the joints, contributes to an increase in the volume of movements. Antipyretic effect is due to a decrease in the excitability of the thermoregulatory centers of the intermediate brain.

Pharmacokinetics:Ibuprofen quickly and almost completely absorbed from the gastrointestinal tract,its maximum concentrations in the plasma are reached after 1 -2 hours after ingestion, in synovial fluid - after 3 hours, binds to plasma proteins by 99%. Slowly penetrates into the joint cavity, lingers in the synovial tissue, creating in it greater concentrations than in the plasma.
Metabolism of ibuprofen occurs mainly in the liver. Half-life (T_1/2) from the plasma is 2-3 hours. It is excreted by the kidneys in the form of metabolites (in the unchanged form, no more than 1% is excreted), to a lesser extent - with bile. Ibuprofen fully output in 24 hours.

Indications:Salpaflex tablets are used to relieve headache, including tension headache and migraine, articular, muscle pain, back pain, lower back, sciatica, pain in case of ligament damage, dental pain, painful menstruation, fever, with colds, flu , with rheumatoid arthritis, osteoarthritis.

Contraindications:- hypersensitivity to any of the ingredients that make up the drug.
- erosive and ulcerative changes in the mucosa of the stomach or duodenum, active gastrointestinal bleeding;
- inflammatory bowel disease in the acute phase, incl. nonspecific ulcerative colitis;
- anamnestic data on the attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, asthma);
- liver failure or active liver disease;
- renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease;
- confirmed hyperkalemia;
- hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis.
- in the period after aorto-coronary bypass surgery;
- Pregnancy (III trimester).
- Children under 12 years old.

Carefully:Elderly age, congestive heart failure, cerebrovascular disease, hypertension, ischemic heart disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, nephrotic syndrome, creatinine clearance less than 60 ml / min, hyperbilirubinemia,stomach ulcer and duodenal ulcer (in the anamnesis), presence of Helicobacter pylori infection, gastritis, enteritis, colitis, prolonged use of NSAIDs, blood diseases of unclear etiology (leukopenia and anemia), pregnancy (I-II) trimester, lactation period, smoking, frequent alcohol use, severe physical illness, concomitant therapy with the following drugs: anticoagulants (for example, warfarin), antiplatelet agents (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).

Dosing and Administration:Adults, seniors and children over 12 years: 1 - 2 tablets up to 3 times a day. Tablets should be swallowed by washing with water, preferably during or after a meal. Do not take more than 6 tablets within 24 hours. Do not take more than 4 hours.
Do not exceed the indicated dose!
The course of treatment without consulting a doctor should not exceed 10 days.
If symptoms persist, consult a physician.

Side effects:In recommended doses, the drug usually does not cause side effects.
Side effect
Cases are described (rarely found):
- Gastrointestinal tract (GIT)
NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, rarely - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding, irritation or dryness of the oral mucosa, mouth pain, ulceration of the mucosa gums, aphthous stomatitis, pancreatitis.
- Hepatobiliary system
Hepatitis.
- Respiratory system
Shortness of breath, bronchospasm.
- Sense organs
Hearing impairment: hearing loss, ringing or tinnitus; visual impairment: toxic damage to the optic nerve, blurred vision or double vision, scotoma, dryness and irritation of the eyes, edema of the conjunctiva and eyelids (allergic genesis).
- Central and peripheral nervous system
Headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, rarely - aseptic meningitis (more often in patients with autoimmune diseases).
- The cardiovascular system
Heart failure, tachycardia, increased blood pressure.
- Urinary system
Acute renal failure, allergic nephritis, nephrotic syndrome (edema), polyuria, cystitis.
- Allergic reactions
Skin rash (usually erythematous or urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnoea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
- Hematopoietic organs
Anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.
- Laboratory indicators:
- time of bleeding (may increase)
- the concentration of glucose in the serum (may decrease)
- clearance of creatinine (may decrease)
- Hematocrit or hemoglobin (may decrease)
- serum creatinine concentration (may increase)
- activity of "liver" transaminases (may increase)
If taking the drug caused a change in your usual condition, stop taking the Solpaflex tablets and immediately consult a doctor.

Overdose:Do not exceed the indicated dosage.If you exceed the dose, contact your doctor or nearest medical institution immediately. Bring the package of the drug with you.
Symptoms of overdose - abdominal pain, nausea, vomiting, retardation, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, lowering blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest. First aid - washing the stomach (only for an hour after taking), Activated carbon, alkaline drink.

Interaction:In therapeutic doses ibuprofen does not enter into significant interactions with widely used drugs.
Inductors of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, zixorin, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication. Inhibitors of microsomal oxidation - reduce the risk of hepatotoxic action.
Reduces the hypotensive activity of vasodilators and natriuretic effect of furosemide and hypothiazide.
Reduces the effectiveness of uricosuric drugs. Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding). Increases the side effects of mineralocorticosteroids, glucocorticosteroids (increases the risk of gastrointestinal bleeding), estrogens, ethanol; enhances the hypoglycemic effect of sulfonylurea derivatives. Antacids and colestramine reduce the absorption of ibuprofen. Increases the concentration in the blood of digoxin, lithium and methotrexate.
Simultaneous administration of other NSAIDs increases the incidence of side effects. Caffeine strengthens the analgesic effect.
With simultaneous appointment ibuprofen reduces inflammatory and antiplatelet effect of acetylsalicylic acid (may increase the incidence of acute coronary insufficiency in patients receiving as antiplatelet agents acetylsalicylic acid, low dose, after initiation of ibuprofen).
Cefamandol, cefaperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia with simultaneous administration.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.
Drugs that block tubular secretion, reduce excretion and increase the plasma concentration of ibuprofen.

Special instructions:With long-term use, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.
To reduce the risk of developing adverse events from the gastrointestinal tract, use a minimally effective dose with the minimum possible short course. If symptoms of gastropathy appear, consult a doctor.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.
During the drug should refrain from drinking alcohol.

Form release / dosage:Film coated tablets.

Packaging:For 6 or 12 tablets in a PVC blister, aluminum foil. 1 or 2 blisters are placed in a cardboard box together with an instruction for use.

Storage conditions:At a temperature of no higher than 25 ° C.
Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date indicated on the. packaging.

Terms of leave from pharmacies:Without recipe

Registration number:П N011299 / 01

Date of registration:01.07.2008

Expiration Date:Unlimited

The owner of the registration certificate: GlaxoSmithClean Consumer Helscher GlaxoSmithClean Consumer Helscher United Kingdom

Manufacturer: & nbsp

GlaxoSmithKline Dungarvan, Ltd. Ireland

Representation: & nbspGlaxoSmithKline Helsker GlaxoSmithKline Helsker United Kingdom

Information update date: & nbsp2016-12-21

Illustrated instructions

Instructions

Solphaflex (Solpaflex)